Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.
Department of Gastroenterology & Hepatology, Auckland City Hospital, Auckland, New Zealand.
J Crohns Colitis. 2022 Aug 30;16(8):1222-1234. doi: 10.1093/ecco-jcc/jjac030.
The UNIFI long-term extension [LTE] study reports the efficacy and safety of subcutaneous 90 mg ustekinumab through 3 years of maintenance therapy.
Patients randomised to ustekinumab every 12 weeks [q12w] or every 8 weeks [q8w] at maintenance baseline [N = 348] and randomised ustekinumab-treated patients in the LTE [N = 284] were evaluated. Symptomatic remission [Mayo stool frequency = 0/1, rectal bleeding = 0] was assessed. Safety included all LTE patients [N = 188 placebo and N = 457 ustekinumab].
Among patients randomised to the ustekinumab q12w and q8w groups at maintenance baseline, 54.1% and 56.3% achieved symptomatic remission at Week 152, respectively. Overall, 20% of patients discontinued ustekinumab, 10% of biologic-naïve and 30% of biologic-exposed patients. Among patients in symptomatic remission at Year 3, 94.6% and 98.0% of patients were also corticosteroid free, respectively. Corticosteroid-free symptomatic remission rates in the ustekinumab q12w and q8w groups were 51.2% and 55.1% at Week 152, respectively. Remission rates were higher for biologic-naïve patients than for those with a history of biologic failure. Biochemical evidence of response was demonstrated by stable, decreased C-reactive protein and faecal calprotectin measurements over 3 years. From Weeks 96 to 156, no deaths, major adverse cardiovascular events, or tuberculosis occurred. Nasopharyngitis, ulcerative colitis, and upper respiratory tract infection were most frequently reported. One ustekinumab-treated patient with a history of basal cell carcinoma [BCC] reported two BCCs. One patient in the q8w ustekinumab group, who was receiving concomitant 6-mercaptopurine, experienced serious adverse events of neutropenic sepsis and oral herpes.
Efficacy of ustekinumab in patients with ulcerative colitis was confirmed through 3 years. No new safety signals were observed.
UNIFI 长期扩展（LTE）研究报告了皮下注射 90 mg 乌司奴单抗维持治疗 3 年的疗效和安全性。
在维持治疗基线时随机接受乌司奴单抗每 12 周（q12w）或每 8 周（q8w）治疗的患者（n = 348）和 LTE 中随机接受乌司奴单抗治疗的患者（n = 284）进行评估。评估症状缓解情况[Mayo 粪便频率=0/1，直肠出血=0]。安全性包括所有 LTE 患者（n = 188 例安慰剂和 n = 457 例乌司奴单抗）。
在维持治疗基线时随机接受乌司奴单抗 q12w 和 q8w 治疗的患者中，分别有 54.1%和 56.3%在第 152 周达到症状缓解。总体而言，20%的患者停用了乌司奴单抗，10%的生物初治患者和 30%的生物暴露患者。在第 3 年时处于症状缓解的患者中，分别有 94.6%和 98.0%的患者无皮质类固醇治疗。乌司奴单抗 q12w 和 q8w 组在第 152 周时无皮质类固醇治疗的症状缓解率分别为 51.2%和 55.1%。生物初治患者的缓解率高于有生物失败史的患者。通过 3 年稳定、降低的 C 反应蛋白和粪便钙卫蛋白测量，显示出了生化缓解的证据。从第 96 周到 156 周，没有死亡、主要不良心血管事件或结核病发生。最常报告的不良反应是鼻咽炎、溃疡性结肠炎和上呼吸道感染。一位有基底细胞癌（BCC）病史的乌司奴单抗治疗患者报告了两次 BCC。接受同时 6-巯基嘌呤治疗的 q8w 乌司奴单抗组的一位患者发生了中性粒细胞减少性脓毒症和口腔疱疹的严重不良事件。
乌司奴单抗治疗溃疡性结肠炎的疗效在 3 年后得到了确认。没有观察到新的安全性信号。
Zotero 插件
